Specialist (m/w/d) External QC Network

Mainz, Germany | full time | Job ID:9793

• Act as a QC point of contact in multidisciplinary project teams to support the implementation of QC project strategies for various protein projects (ADC, mAb, bispecific antibodies)
• Oversee QC-activities at CDMOs and ensure delivery of QC-associated work packages (data evaluation, deviation/OOS-investigations, CoA generation) in time and quality
• Provide technical support in monitoring QC activities at external CDMOs, particularly regarding project tasks and process implementation
• Contribute to the preparation and approval of QC-related GMP documents, test procedures, reports, changes, deviations, and OOS
• Perform raw date checks and evaluation of stability data
• Assist in managing the QC value chain (e.g., release and stability testing) in collaboration with CDMOs and contract laboratories, covering intermediates to finished products

• University degree in a scientific/life-science-related field (M.Sc. would be a plus)
• Proven experience in Quality Control within the biopharmaceutical or biotechnology industry, ideally with exposure to protein projects such as ADCs, mABs, or bispecific antibodies
• Strong knowledge of QC processes, including data evaluation, deviation/OOS investigations, CoA generation, and GMP documentation (e.g., test procedures, reports, raw data checks, and stability testing/evaluation)
• Ideally experience in working with CDMOs or contract laboratories, including oversight of QC activities and ensuring compliance with timelines and quality standards
• Analytical background with proteins and antibodies is a plus
• Ability to manage multiple QC-related tasks simultaneously
• Fluent English (both oral and written)

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare